Product Focus: Electronic Laboratory Notebooks

Although the electronic laboratory notebook (ELN) market is mature, it has undergone several cycles during the past three decades. This existential back-and-forth has centered on whether ELNs should primarily serve as direct replacements for paper notebooks or something more.

Simpler implementation, more accessibility

Today, the marketplace demands that in addition to serving as electronic repositories for intellectual properties, ELNs should foster collaboration within business units or research silos of large R&D organizations.

Early on, ELNs followed development paths similar to that of laboratory information management systems, where installations catered to one type of work, for example, analytical chemistry. Modern ELNs incorporate modules that handle numerous workflow types and “allow deep verticalization that supports sharing,” according to Weiss.

The evolution from thin, horizontal “paper on glass” ELNs is in direct response to the complexities of modern scientific workflows.

While adding features and capabilities, developers have made ELNs easier to use and more accessible. Again, this is a response to the reality of lab workers who are computer savvy but resist steep learning curves for new software. “They take as a given that technology should be easy to use,” Weiss says, “and products that are easy to use ultimately have a lower cost of ownership.”

Originally, IDBS ELNs were based on a Microsoft Windows and Java operating system. This platform limits how and where laboratories could tap into ELN resources. Thus, IDBS and other vendors have moved entire installations to the Web, making many ELN features accessible through tablets and other mobile devices. Computer platform neutrality capabilities improve accessibility by allowing users to work remotely on the device of their choice and by freeing access and operation from any particular computer operating system.

De-siloing

Early ELNs were industry-specific to the point where chemical, environmental, and biology labs sourced their products from different vendors with reputations for particular industries. That is no longer true, says Leif Pedersen, senior VP of marketing and product management at Accelrys (San Diego, CA). “Out-of-the-box implementation makes it easier to adopt new software releases, integrate with other software, and derive other values.”

ELNs have matured to the point where all leading products serve all fields equally well. Leading stand-alone ELNs of 2014 should register novel intellectual property from biology labs as easily as from chemistry labs, a capability that required extra work with ELNs of a decade ago.

Why the interest?

Several factors explain the uptick in interest in ELNs. One is the realization that ELNs are truly universal tools. Instead of purchasing one ELN for chemistry, a different product for biology, and versions each for upstream and downstream activities, a pharmaceutical company, for example, can make everything work on one platform.

Second, organizations can now ease their way into ELNs as never before. Instead of plunging into the software, labs can now take a stepwise approach. The first step can be as simple as creating a data repository that mirrors paper notebooks—paper on glass is the operative term.

Perhaps the most significant factor is that companies realize that the cost of not using an ELN is simply too high. Issues related to first-to-file, lost data, the ability to categorize and clone experiments, and regulatory compliance have essentially rendered paper obsolete.

“Software costs are probably not that different from the early days, but efficiencies are higher,” Pedersen explains. “Large companies now need only one product, not several. And the costs of consulting and implementation have fallen significantly, which has driven down the cost of ownership.”

The layered approach

“The world of ELNs is best entered stepwise,” says Garrett Mullen, senior product marketing manager for NuGenesis products at Waters (Milford, MA). That is how best-in-class companies work today, particularly with ELN-naïve customers.

ELNs that have an SDMS component can capture data from networked computers and equipment such as pH meters and spectrophotometers, manage samples, and at the highest level participate in lab execution processes such as managing instruments, enabling stability study management, and ensuring compliance. The varied deployment levels underscore the need to take things one step at a time.

At its simplest implementation, an ELN uses data management software to capture, store, and organize metadata within a centralized, secure repository. The next stage involves building a test execution system on top of data storage to leverage that data to create a laboratory management system.

“At this stage you’re ready to implement inventories of instruments and reagents that can manage instrument calibrations, help maintain reagent stocks using volume subtractions, and send notices for reorder,” Mullen adds. At this stage of the business, paybacks become tangible. ELNs also assist with corrective actions. In the case of an instrument calibration that may compromise product quality, issues can now be easily identified and understood. Finally, the ELN moves toward more complex operations such as assigning tests and managing stability studies.

At what step does this evolving information technology project become an ELN?

“It begins when the system manages test execution, when you’re able to digitize a process for creating buffers or reagents and plug in sample preparation protocols,” Mullen says. “That’s the all-important lab execution level, when the full functionality of an electronic notebook is realized.”

This is the stage where tests and assays are automatically digitized and users create templates applicable to multiple workflows. “It’s a lot like Lego blocks,” Mullen says. “You don’t need to create a new component each time.”

Lab managers should avoid technology for technology’s sake, however. “Automating because you sense the need to automate is an insufficient motivator for installing an ELN,” Mullen cautions. “There has to be a business benefit that improves productivity and quality, safeguards your business, and reduces the risk of failing an audit.”

For additional resources on electronic laboratory notebooks, including useful articles and a list of manufacturers, visit www.labmanager.com/ELN

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